Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
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Gemstar devices utilizing the pc application are capable of being programmed for a bolus lower lockout limit interval less than the programmed hard limit value stored in the gemstar sp infusion suite database pc application. this could potentially result in the infuser granting more frequent bolus delivery requests than intended in programming the hard limit potentially causing over-delivery of medication to the patient.